510(k) · Decided
DecidedOves Cervical Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Veos, Ltd. · HDR Cap, Cervical
Cleared on Mar 21, 2000 after a 120-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Mar 21, 2000
- Review
- 120 days
- Class
- Class II
- Product code
- HDR
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK993953 Oves Cervical CapVeos, Ltd. · 2000
- Descendant · cites it directly · 3 of its ownK063227 Conceivex Conception KitConceivex, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK222969 FERTI-LILY Conception CupRosesta Medical BV · 2023
- Descendant · 2 generations on · 1 of its ownK112200 Focus Touch Conception SystemIntimate Bridge 2 Conception, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK242031 Béa Applicator (BAP-GB-01)Stepone Fertility Ltd (T/A Béa Fertility) · 2025
- Descendant · 3 generations on · 0 of its ownK140186 The Stork OtcRinovum Women'S Health, Inc. · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K063227Conceivex Conception KitConceivex, Inc. · 2007 · cites it directly3descendants
- K222969FERTI-LILY Conception CupRosesta Medical BV · 2023 · cites it directly1descendant
- K112200Focus Touch Conception SystemIntimate Bridge 2 Conception, Inc. · 2012 · 2 generations on1descendant
- K242031Béa Applicator (BAP-GB-01)Stepone Fertility Ltd (T/A Béa Fertility) · 2025 · 2 generations on0descendants
- K140186The Stork OtcRinovum Women'S Health, Inc. · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993953 | Oves Cervical Cap | Veos, Ltd. | 2000 | — |
| +1 | K063227 | Conceivex Conception Kit | Conceivex, Inc. | 2007 | — |
| +1 | K222969 | FERTI-LILY Conception Cup | Rosesta Medical BV | 2023 | — |
| +2 | K112200 | Focus Touch Conception System | Intimate Bridge 2 Conception, Inc. | 2012 | — |
| +2 | K242031 | Béa Applicator (BAP-GB-01) | Stepone Fertility Ltd (T/A Béa Fertility) | 2025 | — |
| +3 | K140186 | The Stork Otc | Rinovum Women'S Health, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HDR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HDR device
- #1 K242031 Béa Applicator (BAP-GB-01)score 9.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K063227 (Conceivex, Inc., 2007) has gone furthest, with 3 descendants of its own.
How does its category compare?
All HDR devicesHDR Cap, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HDR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HDR
Too few HDR 510(k)s in any year since 2007 to give a median.
Recalls per year · HDR
No recall names HDR since 2007.
Adverse event reports per year · HDR
1in 2014
MAUDE reports naming product code HDR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Oves Cervical Cap is indicated for use in artificial insemination procedures in situations in which low sperm count, sperm immotility, or hostile vaginal environment have been diagnosed.
The Oves Cervical Cap removes semen from the vaginal environment and concentrates the sperm at the opening of the cervical os, thus facilitating sperm contact with cervical mucosa.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993953: Oves Cervical Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993953
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026